EUCTR2005-002409-21-DE进行中（未招募）不适用
A dose-finding randomized clinical trial to evaluate the differential impact of four progestins for their use as male contraceptives in healthy men.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •Men who meet all the following criteria are eligible for enrolment in the trial:
- •1. Caucasian male volunteers in good health
- •2. 18 to 50 years of age
- •3. BMI= 33
- •4. Not using hormonal therapy in the last six months
- •5. Subject or his partner is willing to use a recognized effective method of contraception
- •6. In the opinion of the investigator, is able to comply with the protocol, understand and sign an informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Men who meet all the following criteria are not eligible for enrolment in the trial:
- •2. Men participating in another clinical trial
- •3. Men not living in the catchment area of the clinic
- •4. Clinically significant abnormal findings at screening
- •5. Elevated prostate specific antigen (PSA), according to local laboratory normal values
- •6. Abnormal serum chemistry values according to local laboratory normal values, which indicate liver or kidney dysfunction. Other abnormal lab values may also be exclusionary, at the discretion of the investigator. The investigator will use the following criteria for exclusion:
- •- liver function test abnormalities of greater than 1.5 times the upper limit of normal
- •- abormal prolactin level (1.5 times the upper limit of normal)
- •7. History of sleep apnea and/or psychiatric problems
- •8. History of hepatitis A, B or C
- •9. Using androgens or body building substances
- •10. Diastolic blood pressure (BP) = 90 and systolic BP= 140 mmHg
- •11. History of hypertension, including hypertension controlled with treatment
- •12. Known history of primary testicular disease or disorders of the hypothalamic-pituitary axis
- •13. Known history of prostatic diseases or disorders
- •14. Known family history of prostate cancer
- •15. Known hypersensitivity to progestins
- •16. Contraindications to the progestins as per package insert
- •17. History of venous thromboembolism
- •18. Benign or malignant liver tumors; active liver disease
- •19. Known history of reproductive dysfunction including vasectomy or infertility
- •20. Known or suspected alcoholism or drug abuse
- •21. Excessive alcohol consumption, according to the investigator's judgement
- •22. Known dermatitis or severe skin disorder
- •The following termination criteria will be used to exclude the subjects at any time before or during the study:
- •- hemoglobin levels above 18.0 g/L
- •- confirmed elevations of AST, ALT, or alkaline phosphatase above three times upper normal.
- •Men desiring fertility within 6 months or participating in competitive sports where drug screening for prohibited substances (including anabolic steroids) is routine will be advised of the relative and temporary hazards that participating in this study may have for their fertility or sporting status.
研究者
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